Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494696
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
68Ga-PSMA PETMRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Utilizing 68Ga-PSMA PETMRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn if Ga-68 PSMA PETMRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms The main questions it aims to answer are
1 Does PSMA PETMRI have better PPV and NPV than mpMRI to diagnose prostate cancer
2 Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy
Participants will
1 Undergo a Ga-68 PSMA PETMRI scan and keep followed up for 2 years to check if prostate cancer is diagnosed after the scan
2 Between the follow-up period visit the clinic once every 6 months for checkups and blood tests
1 Does PSMA PETMRI have better PPV and NPV than mpMRI to diagnose prostate cancer
2 Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy
Participants will
1 Undergo a Ga-68 PSMA PETMRI scan and keep followed up for 2 years to check if prostate cancer is diagnosed after the scan
2 Between the follow-up period visit the clinic once every 6 months for checkups and blood tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None